Medical device labelling Date of manufacture

Aafaf

Registered
#1
Hello everybody,
Has the date of manufacture to appear on the labeling of a medical device destined for the United States, if it does not have an expiration date?

Thanls
 
Last edited:
Elsmar Forum Sponsor

Edward Reesor

Trusted Information Resource
#2
I don't believe it has to be present, as suggested when registering the device on the GUDID site where you must respond to a "Yes" or "No".
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Aafaf

Registered
#3
Thanks,

As in Europe, we have this requirement: "The label shall bear all of the following particulars: [...] where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;" I was wondering if there was an equivalence in the USA.
 
Last edited:

LUFAN

Involved In Discussions
#4
Thanks,

As in Europe, we have this requirement: "The label shall bear all of the following particulars: [...] where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;" I was wondering if there was an equivalence in the USA.
There is no direct QSR requirement, however, the new ISO 24071 document requires it. Would not surprise me to see that become a requirement an FDA requirement with 13485 alignment in near future.
 
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